BD Receives FDA 510(k) Clearance for Rapid Point-of-Care COVID-19 Test

Original from: Becton, Dickinson and Compan

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Veritor™ System for SARS-CoV-2, a digital test designed to detect COVID-19 antigens in symptomatic individuals in about 15 minutes at doctors' offices, urgent care centers, retail clinics and other convenient points of care.

The BD Veritor™ System for SARS-CoV-2 has been available under Emergency Use Authorization (EUA) from the FDA since September 2020. The new 510(k) clearance will eventually replace the current EUA version of the test, starting in early fall 2025.

"This FDA clearance is part of our ongoing commitment to support health care providers with reliable, rapid diagnostic tools," said Nikos Pavlidis, worldwide president of BD Diagnostic Solutions. "The BD Veritor™ System for SARS-CoV-2 has proven to be a reliable COVID-19 test with a streamlined workflow and clear digital results, helping clinicians make confident and timely decisions that can help improve patient outcomes."

The BD Veritor™ System for SARS-CoV-2 is a chromatographic, digital lateral flow immunoassay that delivers objective, easy-to-read results using the BD Veritor™ Plus Analyzer. The test is intended for use in CLIA-waived environments and provides results from nasal swab specimens from patients within six days of symptom onset.

Source: BD Receives FDA 510(k) Clearance for Rapid Point-of-Care COVID-19 Test